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Pembrolizumab Post-IMRT for Thyroid Cancer

Phase 2
Recruiting
Led By Maria Cabanillas
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stage IVB disease with unresectable disease or complete resection of tumor without convincing evidence of metastatic disease in the neck
Male/female participants who are at least 18 years of age with pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial will study the use of the drug pembrolizumab as an adjuvant (additional) treatment to radiation in patients with stage IVB cancer that has spread to the neck. The aim is to estimate how well the pembrolizumab works in prolonging the progression-free survival in these patients.

Who is the study for?
This trial is for adults with stage IVB anaplastic thyroid cancer (ATC) who have completed radiation therapy, possibly with chemotherapy. They must be in good health overall, not pregnant or breastfeeding, and willing to use contraception. Those with certain prior treatments or immunodeficiencies, recent vaccinations, or specific genetic mutations are excluded.Check my eligibility
What is being tested?
The trial tests pembrolizumab as an additional treatment after radiation for ATC. It aims to see how long patients can live without their cancer getting worse after this combination of therapies. Participants will receive pembrolizumab following either high-dose (>51 Gy) or lower-dose (<50 Gy) radiation.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs like the lungs and intestines, skin reactions, hormone gland problems (like thyroid), fatigue, infusion reactions and could potentially worsen pre-existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced but hasn’t spread to my neck.
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I am 18 or older with a diagnosis of anaplastic thyroid cancer.
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I am fully active or can carry out light work.
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I have finished radiation therapy, with or without chemotherapy.
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My organs are working well.
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I am not pregnant, not breastfeeding, and follow birth control guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To establish the median progression-free survival (PFS).

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
The infusions are given every 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,330 Total Patients Enrolled
Maria CabanillasPrincipal InvestigatorM.D. Anderson Cancer Center
Maria Cabanillas, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT05059470 — Phase 2
Thyroid Research Study Groups: Pembrolizumab
Thyroid Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05059470 — Phase 2
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05059470 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new patients being accepted into this research study?

"The medical trial is still looking for patients, as of July 18th, 2022. This information can be found on clinicaltrials.gov, which also reports that the study was first posted on February 11th, 2020. They are recruiting for 35 participants from 1 location."

Answered by AI

What other instances of research have there been with Pembrolizumab?

"Pembrolizumab is being trialed in 1000 different ongoing studies, with 122 of them in Phase 3. The majority of these trials are based in Houston, Texas; however, there are 36030 locations running Pembrolizumab clinical trials globally."

Answered by AI

How many individuals are being monitored in this clinical research?

"That is accurate. The information available on clinicaltrials.gov reveals that this research is looking for volunteers at the moment. This study was first announced on February 11th, 2022 and has had one update since then on July 18th, 2022. So far, only 1 out of the 35 needed participants have been recruited."

Answered by AI

What conditions does Pembrolizumab help to treat?

"Pembrolizumab can be used to fight three different types of cancer: malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

Could you please provide more information on the risks of Pembrolizumab?

"Pembrolizumab falls into Phase 2 of clinical trials, meaning that while there is some data supporting its safety, there is currently no evidence to suggest that it is effective."

Answered by AI
~8 spots leftby Dec 2024